SALT LAKE CITY -- A Salt Lake City medical manufacturer has been shut down after the U.S. Food and Drug Administration said its surgical imaging devices could put patients at risk.
The FDA announced a consent decree with GE OEC Medical Systems on Friday, four months after an audit showed violations of federal quality assurance regulations. The company, a subsidiary of General Electric since 1999, stopped shipping its fluoroscopic X-ray and navigation systems following the audit.
"These devices are used on thousands of patients, and their dependability and accuracy are critical for the successful outcomes of important medical procedures," according to Daniel Schulz, director of the FDA's Center for Devices and Radiological Health.
Under the FDA agreement, GE OEC, can't manufacture or sell equipment until it complies with federal law. The agreement affects a Utah plant and a GE Healthcare plant in Lawrence, Mass. About 30 Utah employees have been placed on furlough.
Doctors commonly use the C-arm X-ray machines to see inside the body during minimally invasive orthopedic, cardiac and vascular surgeries.
GE Healthcare had previously recalled the devices after learning that in some circumstances patients could be exposed to excessive radiation. The machines could also loose or mixup patient images after a procedure.
"The company takes FDA observations very seriously and is working aggressively to address and resolve the issues identified as quickly as possible," GE Healthcare spokesman Brian McKaig said.
Included in the conditions of the decree, GE Healthcare must hire an independent expert to inspect the Utah and Massachusetts plants to make sure corrective measures are implemented.
FDA officials sent a warning letters to the Utah plant in March 2005, noting quality control problems in manufacturing, packaging and equipment installation.
This story appeared in The Daily Herald on page B5.
Posted in Local on Saturday, January 13, 2007 11:00 pm
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